Drainage After Rectal Excision for Rectal Cancer (NCT01269567) | Clinical Trial Compass
CompletedPhase 3
Drainage After Rectal Excision for Rectal Cancer
France494 participantsStarted 2011-01
Plain-language summary
After rectal excision, the rate of anastomotic leak and abscess is higher than after colic surgery. In order to limit and avoid the risk of pelvic sepsis after rectal excision, a prophylactic pelvic drainage is usually used. If current data have confirmed the uselessness of drainage in colic surgery, the question stay in abeyance in rectal surgery. This practice had never been evaluated in patients with rectal excision and low anastomosis (patients with a high risk of pelvic sepsis)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Rectal adenocarcinoma, histopathologically proved, with or without neoadjuvant treatment
* Stapler or manual infraperitoneal anastomosis
* With or without stoma
* With bowel preparation
* Open or laparoscopic approach
* Stage T1-T4 Nx Mx
* Age 18 years old or older
* Information of the patient and signature of informed consent
* Affiliation to a regime of social insurance
Exclusion Criteria:
* Colonic cancer (\> 15 cm from anal verge)
* Abdominoperineal resection
* Associated resection (prostate, seminal bladder, vagina…)
* Simultaneous liver resection
* Total coloproctectomy
* Emergency
* Infected rectal tumour
* Pregnant women, suitable to be, or current suckling
* Persons deprived of freedom or under guardianship
* Persons under protection of justice
* Impossibility to accept the medical follow-up of the study for geographic , social or psychic reasons.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.